The Underlying Mechanisms Regarding the Effect of Glucagon on the Kidneys Will be Investigated in Healthy Males.

NCT06498063 | Recruiting

• 3 other identifiers: H-2201948320-1914; 21-1518NNF21OC0070308
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this crossover study is to investigate to what extend glucagon affects the kidneys. The main questions it aims to answer are: Does glucagon regulate kidney function through extraction in the kidney in addition to glomerular filtration? Does glucagon regulate kidney function by increasing renal plasma flow and glomerular filtration rate? Does glucagon regulate kidney function by increasing renal salt excretion?

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• Natriuresis

  From urine samples, unit mmol/L

  Analyzed from urine samples at -60, 0, 60 and 120 minutes

• Glucagon extraction

  From blood samples, unit pmol/L

  Analyzed from blood samples drawn at -30, 0, 20, 40, 60, 80, 100, 120, 140, 160 and 180 minutes

Secondary Outcomes (4)

• Glomerular filtration rate

  Measured via Fick's principle during steady state using [99mTc]Tc-DTPA (diethylene-triamine-pentaacetate) as a tracer given as a constant infusion from -210 to 180 min.

• Diuresis

  Analyzed from urine samples at -60, 0, 60 and 120 minutes

• Renal Blood Flow

  Measured via Fick's principle during steady state using [99mTc]Tc-DTPA (diethylene-triamine-pentaacetate) as a tracer given as a constant infusion from -210 to 180 min.

• Urea

  Analyzed from blood samples drawn at -30, 0, 20, 40, 60, 80, 100, 120, 140, 160 and 180 minutes

Study Arms (3)

Glucagon

EXPERIMENTAL

Glucagon infusion of 5 ng·kg-1·min-1 from 0-60 minutes and 10 ng·kg-1 ·min-1 from 60-120 minutes.

Other: Glucagon; Other: Placebo; Other: Glucagon and exendin 9-39

Glucagon+Exendin9-39

EXPERIMENTAL

Glucagon (infusion of 5 ng·kg-1·min-1 from 0-60 minutes) and glucagon (infusion of 10 ng·kg-1 ·min-1 from 60-120 minutes) + a GLP-1R antagonist, exendin 9-39 (900 pmol·kg-1·min-1 from -30-120 minutes).

Other: Glucagon; Other: Placebo; Other: Glucagon and exendin 9-39

Sodium chloride (Placebo comparator)

PLACEBO COMPARATOR

NaCl (0.9%)

Other: Glucagon; Other: Placebo; Other: Glucagon and exendin 9-39

Interventions

Glucagon OTHER

Glucagon infusion of 5 ng·kg-1·min-1 from 0-60 minutes and 10 ng·kg-1 ·min-1 from 60-120 minutes.

Glucagon; Glucagon+Exendin9-39; Sodium chloride (Placebo comparator)

Placebo OTHER

Placebo (0.9% NaCl).

Glucagon; Glucagon+Exendin9-39; Sodium chloride (Placebo comparator)

Glucagon and exendin 9-39 OTHER

Glucagon (infusion of 5 ng·kg-1·min-1 from 0-60 minutes) and glucagon (infusion of 10 ng·kg-1 ·min-1 from 60-120 minutes) + a GLP-1R antagonist, exendin 9-39 (900 pmol·kg-1·min-1 from -30-120 minutes).

Glucagon; Glucagon+Exendin9-39; Sodium chloride (Placebo comparator)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 20-60 years
• Normal health ascertained through questioning and medical examination
• Normal values for blood concentrations of fasting plasma glucose, fasting plasma total cholesterol, fasting triglycerides, HDL, LDL, creatinine, liver function, and electrolytes
• Informed consent

You may not qualify if:

• Immunosuppressive treatment in the preceding 12 months
• Alcohol abuse
• Medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (DPP-4) inhibitors, or GLP-1 receptor agonists, which, in the opinion of the investigator, may interfere with glucose metabolism
• Use of lithium
• Medical treatment that affects insulin secretion or cardiovascular performance measures
• Liver disease (ALT \> 2x normal value)
• Renal impairment (se-creatinine \> 130 μM and/or albuminuria)

Sponsors & Collaborators

• Ali Asmar: lead
• University of Copenhagen: collaborator
• The Augustinus Foundation, Denmark.: collaborator
• The Novo Nordic Foundation: collaborator

Study Sites (1)

Physiological laboratory, Bispebjerg Hospital, Research Unit, Clinical Physiology / Nuclear Medicine Department

Copenhagen, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Kidney Diseases

Interventions

Glucagon; exendin (9-39)

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ali Asmar, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Asmar, MD

CONTACT

800-555-5555; ali.asmar.02@regionh.dk

Anna Billeschou Bomholt

CONTACT

800-555-5555; anna.billeschou@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Associate Professor, PhD, MD

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: July 12, 2024
• Study Start: February 20, 2024
• Primary Completion: March 28, 2025
• Study Completion: July 31, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

DK (1)